Creation date: 02/02/2017 Effective date: 02/02/2017 Review date: - Modification: - 1 Introduction Changes List of Appendixes...

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1 1 Introduction Changes List of Appendixes Introduction Changes to Sixth Edition Cell Therapy Standards and Accreditation Manual The table below outlines the made to the FACT-JACIE Cellular Therapy Accreditation Manual with each version of the sixth edition of this Manual. 1 2 Changes Version Number Standard Change 6.1 A3 CAR (Chimeric antigen receptor) 6.1 A3 CNS (Central nervous system) 6.1 A3 CRS (Cytokine release syndrome) 6.1 A3 MSC (Mesenchymal stromal cell or mesenchymal stem cell) 6.1 A3 NC (Nucleated cell) 6.1 A4 Cellular therapy product: Somatic cell-based product (e.g., mobilized HPC, mononuclear cells, cord blood cells, mesenchymal stromal cells, T cells, natural killer cells) that is procured from a donor and intended for processing and administration. 6.1 A4 Chimeric antigen receptor: Artificial receptor that combines an antigen specificity domain coupled with an intracellular signalling domain typically expressed by an immune effector cell (e.g., T cell or natural killer cell). 6.1 A4 Corrective action: Action taken to eliminate the root causes of an existing discrepancy or other undesirable situation to prevent recurrence. 6.1 A4 Cytokine release syndrome: A non-antigen-specific toxicity that occurs as a result of high-level immune activation. For example, a reaction from the release of cytokines from cells targeted by an antibody or immune effector cells. 6.1 A4 Immune effector cell: A cell that has differentiated into a form capable of modulating or effecting a specific immune response. 6.1 A4 Preventive action: Action taken to eliminate the root cause and prevent occurrence of a potential discrepancy or other undesirable situation. 1 This appendix does not include minor numbering or reorganization that were a result of the substantive listed above. 1/5

2 6.1 A4 Product identity: Unique title that identifies the cellular composition of the product in a way that can be directly tied back to a manufacturing entity or process (e.g., a protocol number, a commercial product title, or a sitedefined unique identifier). 6.1 A4 Quality assurance: The actions, planned and performed, to provide confidence that all systems and elements that influence the quality of the product or service are working as expected or exceed expectations individually and collectively. 6.1 B1.2.1 If cellular therapy products are received directly by the Clinical Program from a third-party provider, the following responsibilities at a minimum shall be defined in a written agreement: 6.1 B Traceability and chain of custody of cellular therapy products. 6.1 B Cellular therapy product storage and distribution. 6.1 B Verification of cellular therapy product identity. 6.1 B Addition of clarifying guidance information. 6.1 B2.6 There shall be written guidelines for communication, patient monitoring, and prompt transfer of patients to an intensive care unit, emergency department, or equivalent when appropriate. 6.1 B2.8.1 Pharmacies shall have access to medications adequate to treat expected complications of immune effector cell administration, including cytokine release syndrome. 6.1 B2.8.1 Addition of guidance information. 6.1 B3.3.3 Clinical Program Directors and attending physicians shall have received specific training and maintain competency in each of the following areas as applicable to the Clinical Program's services: 6.1 B Diagnosis and management of veno-occlusive disease of the liver and other causes of hepatic dysfunction. 6.1 B Management of thrombocytopenia and bleeding, including recognition of disseminated intravascular coagulation. 6.1 B Graft versus host disease. 6.1 B Cytokine release syndrome. 6.1 B Tumour lysis syndrome. 6.1 B Macrophage activation syndrome. 6.1 B Cardiac dysfunction. 6.1 B Renal dysfunction. 6.1 B Respiratory distress. 6.1 B Neurologic toxicity. 6.1 B Anaphylaxis. 2/5

3 6.1 B Infectious and non-infectious processes. 6.1 B Cellular therapy product administration. 6.1 B Care interventions to manage transplant cellular therapy complications, including, but not limited to, cytokine release syndrome, tumour lysis syndrome, cardiac dysfunction, respiratory distress, neurologic toxicity, renal and hepatic failure, disseminated intravascular coagulation, anaphylaxis, neutropenic fever, infectious and non-infectious processes, mucositis, nausea and vomiting, and pain management. 6.1 B Detection and management of immune effector cellular therapy complications including, but not limited to, those listed in B B Addition of guidance. 6.1 B An overview of haematology/oncology patient care, including the cellular therapy process, cytokine release syndrome, and neurological toxicities. 6.1 B3.8.3 Pharmacists should shall be involved in the development and implementation of guidelines or SOPs related to the pharmaceutical management of transplant cellular therapy recipients. 6.1 B Continuing education shall include, but is not limited to, activities related to the field of HPC transplantation and cytokine release syndrome and neurological toxicities resulting from cellular therapies. 6.1 B The Clinical Program Quality Manager should have a reporting structure independent of cellular therapy product manufacturing. 6.1 B4.1.1 Addition of clarifying guidance. 6.1 B4.6.2 Addition of clarifying guidance. 6.1 B For immune effector cells, an endpoint of clinical function as approved by the Clinical Program Director. 6.1 B Addition of guidance. 6.1 B Overall and treatment-related morbidity and mortality at thirty (30) days, one hundred (100) days, and one (1) year after transplantation cellular therapy product administration. 6.1 B Periodic audit of the accuracy of clinical data. 6.1 B Annual audit of safety endpoints and immune effector cellular therapy toxicity management. 6.1 B A thorough investigation shall be conducted by the Clinical Program in collaboration with the Collection Facility, and Processing Facility, and other entities involved in the manufacture of the cellular therapy product, as appropriate. 3/5

4 6.1 B Addition of clarifying guidance. 6.1 B4.12 Addition of clarifying guidance. 6.1 B Management of toxicities of immune effector cellular therapies, including cytokine release syndrome and central nervous system complications. 6.1 B Addition of guidance. 6.1 B6.3.9 Collection from a donor who does not meet Clinical Program collection safety criteria shall require documentation of the rationale for his/her selection by the transplant recipient's physician. 6.1 B6.4.2 Addition of clarifying guidance. 6.1 B Addition of clarifying guidance. 6.1 B7.6.8 Addition of clarifying guidance. 6.1 B7.10 There shall be policies and procedures addressing the administration of immune effector cells and management of complications. 6.1 B There shall be a consultation with the referring physician prior to initiation of immune effector cellular therapy to review the goal and plan of the treatment. 6.1 B There shall be regular assessment of the recipient to detect complications, including cytokine release syndrome and neurologic dysfunction. 6.1 B Addition of guidance. 6.1 B There shall be a written plan for rapid escalation of care, increased intensity of monitoring, and relevant workup to address complications. 6.1 B Communication to the clinical staff, intensive care unit, emergency department, and pharmacy shall be timely. 6.1 B Addition of guidance. 6.1 B The Clinical Program shall have written guidelines for management of complications, including the use of cytokine-blocking agents and corticosteroid administration. 6.1 B Addition of guidance. 6.1 B8.1.2 There shall be a process to manage investigational cellular therapy products. 6.1 B9.1 Addition of clarifying guidance. 6.1 B9.1.2 Addition of clarifying guidance. 6.1 B9.2 The Clinical Program should collect all the data elements included in the applicable CIBMTR Cellular Therapy forms or EBMT forms. 6.1 B9.2 Addition of clarifying guidance. 6.1 B9.3 The Clinical Program shall define staff responsible for collecting data and, as appropriate, reporting data to institutional repositories and CIBMTR or EBMT. 4/5

5 6.1 B10.3 Addition of clarifying guidance. 6.1 C1.2 Addition of clarifying guidance. 6.1 C3.3.2 The Quality Manager should have a reporting structure independent of cellular therapy product manufacturing. 6.1 C Addition of clarifying guidance. 6.1 C6.3.4 Addition of clarifying guidance. 6.1 C7.1.2 Addition of clarifying guidance. 6.1 D3.3.2 The Processing Facility Quality Manager should have a reporting structure independent of cellular therapy product manufacturing. 6.1 D8.1.1 Addition of clarifying guidance 3 List of Appendixes Standards 6.01 ed Manual 6.01 ed Summary of /5